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Quality Assurance Manager / Manager Representative

We are seeking a dedicated and experienced Quality Assurance Manager / Manager Representative to join our team. The ideal candidate will have a strong background in Quality Management Systems (QMS) and the ability to lead a team to ensure compliance with industry standards. Experience in the surgical industry and knowledge of technical drawings management systems is preferred.

Key Responsibilities:

Oversee and manage the Quality Management System (QMS) to ensure it meets industry standards and regulatory requirements.
Lead and coordinate a team of quality assurance professionals.
Maintain and manage technical drawings and related management systems.
Conduct internal and external audits to ensure compliance with ISO 18435 and other relevant standards.
Ensure compliance with Medical Device Regulation (MDR) and Unique Device Identification (UDI) requirements.
Develop, implement, and monitor quality control systems to ensure product quality and compliance.
Identify and address quality issues and implement corrective actions.
Provide training and support to staff on quality management systems and standards.

Qualifications and Experience:

Minimum of a Bachelor's degree in Engineering or a related field; a Master’s degree is preferred.
8 to 10 years of experience in quality assurance, with a preference for experience in the surgical industry.
In-depth knowledge of Quality Management Systems (QMS).
Familiarity with ISO 13485 standards.
Experience with Medical Device Regulation (MDR) and Unique Device Identification (UDI) requirements.
Proven experience in conducting internal and external audits.
Strong leadership and team management skills.
Excellent communication and problem-solving abilities.